Salmonella Typhi Antigen Rapid Test

INTENDED USE

The Salmonellla Typhi Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Salmonellla Typhi Antigens in human stool specimens to aid in the diagnosis of Salmonellla Typhi infection.

MATERIALS

Materials Provided

Materials Required but Not provided

TEST PROCEDURE

Allow the test, reagents, swab specimen, and/or controls to reach room temperature (15-30°C) prior to testing.

1. 1.To collect fecal specimens:

Collect sufficient quantity of feces (1-2 mL or 1-2 g) in a clean, dry specimen collection container to obtain maximum antigens (if present). Best results will be obtained if the assay is performed within 6 hours after collection. Specimen collected may be stored for 3 days at 2-8℃ if not tested within 6 hours. For long term storage, specimens should be kept below -20℃.

2. 2.To process fecal specimens:

• For Solid Specimens:

Unscrew the cap of the specimen collection tube，then randomly stab the specimen collection applicator into the fecal specimen in at least 3 different sites to collect approximately 50mg of feces (equivalent to 1/4 of a pea). Do not scoop the fecal specimen.

• For Liquid Specimens:

Hold the dropper vertically, aspirate fecal specimens, and then transfer 2 drops (approximately 100μL) into the specimen collection tube containing the extraction buffer.

Tighten the cap onto the specimen collection tube, then shake the specimen collection tube vigorously to mix the specimen and the extraction buffer.

3. 3.Bring the pouch to room temperature before opening it. Remove the test cassette from the foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch.
4. 4.Hold the specimen collection tube upright and open the cap onto the specimen collection tube. Invert the specimen collection tube and transfer 3 full drops of the extracted specimen (approximately 120μL) to the specimen well (S) of the test cassette, then start the timer. Avoid trapping air bubbles in the specimen well (S). See illustration below.
5. 5.Read results at 5 minutes after dispensing the specimen. Do not read results after 15 minutes.

Note: If the specimen does not migrate (presence of particles), centrifuge the extracted specimens contained in the extraction buffer vial. Collect 120μL of supernatant, dispense into the specimen well (S) of a new test cassette and start afresh following the instructions mentioned above.

INTERPRETATION OF RESULTS

POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).

NEGATIVE: Only one colored band appears in the control region (C). No apparent colored band appears in the test region (T).

INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.

PERFORMANCE CHARACTERISTICS

Clinical Sensitivity, Specificity and Accuracy

The Salmonellla Typhi Antigen Rapid Test has been evaluated with specimens obtained from a population of symptomatic and asymptomatic individuals. The result shows that the sensitivity of the Salmonellla Typhi Antigen Rapid Test is 96.2% and the specificity is 99.2% relative to other Rapid Test Cassette.

Relative Sensitivity: 97.2% (95%CI: 87.0%-99.5%)  

Relative Specificity: 98.4% (95%CI: 95.7%-100%)

Accuracy: 97.8% (95%CI: 95.2%-99.7%)